Clearance Summary
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS received FDA 510(k) clearance under submission number K012132, sponsored by Cantor & Nissel , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2002-05-09.
- Submission: K012132
- Applicant / Sponsor: Cantor & Nissel , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2002-05-09
Classification & Regulation
This clearance is catalogued under FDA product code NIC and 21 CFR 886.5925, within the Ophthalmic review panel as a Class II device.